The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

NIH Requests Comment on Genomic Data Sharing Policy Draft

Last month, the National Institutes of Health (NIH) published a draft version of its new genomic data sharing policy, along with a request for public comment. The draft policy parallels some of the concepts and recommendations discussed in the Presidential Commission for the Study of Bioethical Issues’ (Bioethics Commission) 2012 report: Privacy and Progress in Whole Genome Sequencing. The Bioethics Commission is pleased to note that several of its recommendations and core ethical principles are shared by NIH and other law and policymakers.

The Bioethics Commission’s recommends in Privacy and Progress (Recommendation 1.1) that “Funders of whole genome sequencing research… should maintain or establish clear policies defining acceptable access to and permissible uses of whole genome sequence data.”  The NIH draft policy does just that: it defines the requirements for access to and use of genomic data, and sets forth the guiding ethical principles for the responsible use of such data.

The NIH draft policy states its purpose as encouraging broad sharing of genomic data, in order to facilitate important advancements in medicine, while also ensuring its responsible and ethical use. Similarly, the Bioethics Commission recognized the need to reconcile the enormous potential for public benefit derived from genomic research with individual privacy protections.

The NIH draft policy, like Privacy and Progress, highlights two centrally important ethical principles guiding the use of genomic data: respect for persons and responsible stewardship. The Bioethics Commission explained that respect for persons calls for strong baseline protections for the privacy of human research participants, and responsible stewardship calls for oversight and management of genomic data by the funders and managers of such data. The NIH draft policy aims to achieve both goals by strengthening privacy protections, and by standardizing and overseeing important security measures – like the deidentification of genetic data – a practice consistent with the Bioethics Commission’s recommendations.

The Bioethics Commission also maintained that like data should be treated alike, regardless of context.  In Privacy and Progress it recommended robust and workable informed consent procedures for genomic data used in research, whether they were generated in the course of research or in a clinical setting (Recommendation 3.1). The NIH draft policy states that all genomic data submitted to the database in the future must be obtained with informed consent, including when they were obtained in a clinical setting. This equalizes treatment of data irrespective of source.

The draft NIH genomic data sharing policy encourages sharing of and access to genomic data, in order to advance scientific progress, while maintaining a strict baseline level of privacy controls. Its goal is to protect participants from whom the data were collected and derived. The similarities between the NIH draft policy and the Bioethics Commission report highlight the importance of protecting individual privacy while facilitating progress, and further reinforce the core ethical principles behind each.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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